FDA Adverse Event
Malfunction
Summary report: N
9616240-2006-00344
MDR report key: 727533
·
Received June 14, 2006
Report
- Report Number
- 9616240-2006-00344
- Event Type
- Malfunction
- Date Received
- June 14, 2006
- Product Code
- KDI
- PMA / PMN Number
- k010805
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
NO PT'S INFO WAS REPORTED. MORE INFO WAS ASKED REGARDING THE REPORTED INCIDENT. TO DATE, NO ADDITIONAL INFO WAS PROVIDED. CLINICAL INVESTIGATION IS ONGOING. 510(K)# IS K010805
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KDI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |